Summary
Synthetic data emerges as a potential solution to privacy concerns in healthcare, allowing the use of realistic but artificial datasets to ensure data security and compliance. Meanwhile, challenges persist in decentralized trials and AI applications in medicine, such as ensuring data protection, managing bias, and maintaining patient rights when AI influences clinical trial participation. Regulatory bodies like the FTC are enforcing stricter data handling practices for health apps, and new legislative initiatives, such as the UK’s “Data Protection and Digital Information Bill” and the EU’s forthcoming pharmaceutical reform, aim to address data protection and healthcare accessibility issues amid evolving technological and societal demands.
BioTech & MedTech
Synthetic Data: the answer to privacy issues?
Synthetic Data could be the answer to many questions about security and privacy. Real world data oftentimes contains sensible data and thus has to be thoroughly protected to respect security and privacy principles. Synthetic data is currently being developed, most notably to answer those questions about security and privacy.
Data Silos And The GDPR
Data Silos are an ongoing problem for many companies but even more so for Life sciences companies. They are most of the time obstacles to an analysis of the data as well as to the accessibility and interoperability of data. It is necessary for companies to have the right tools to de-silo the data. Furthermore, a sound decision making is needed, especially for data concerning EU citizens. The GDPR imposes two principles concerning this data: the data minimisation principle and the purpose limitation. Not all data should be collected and stored. A choice must be made.
The Progress Made For Decentralized Trials
Decentralized trials have privacy and security issues. The development of new technology could help to limitate the security issue, notably by processing patient-generated data securely in real time. Decentralized trials could use edge computing or federal computing. But this still poses some problems for the privacy issues.
Artificial Intelligence
ChatGPT As A Doctor?
ChatGPT passed the United States Medical Licensing Exam (USMLE), an exam required in the US for medical licensure. But is it ready to be deployed in real conditions? An ER Doctor tested ChatGPT with the data that he collected on his patients and evaluated the diagnosis made by ChatGPT. The AI has an important bias and used as such it won’t be able to establish the right diagnostic. It could be used in the future as a tool to help a diagnosis thanks to a multitude of data that it collected over the years.
The problem here is the collection of the patients' health data. Furthermore, to be efficient, it needs many categories of data, such as real world data. The question of the protection of the data has to be made clear.
Europe And AI Involved In The Medical Field
The European Regulators are conscious of the impact of drugs made with the input of an AI. The need for a regulation is apparent. Nevertheless, some warn against over-regulation that could stifle the innovation.
The use of AI still makes many issues apparent. For example, if an AI decides itself which patients can join a clinical trial based on how it expects them to respond to the drugs, many challenges must be faced. First among them are the security and integrity of the data. How would it access the data? How would it make its choice? On what basis? AI is very promising, but it also has to be used prudently so as not to infringe on the rights of the patients.
Digital Therapeutics
Health Apps And The Federal Trade Commission
The past few months many health applications were condemned for sharing their data with advertisers or for mishandling the user's data.
The Federal Trade Commission (FTC) is enforcing the Health Breach Notification Rule which requires vendors of personal health records to notify the FTC and consumers in the event of a breach of unsecured identifiable health information. The FTC could enforce the Rule against BetterHelp and GoodRx thanks to a guidance issued by the U.S Department of Health and Human Services’ Office for Civil Rights (OCR).
Health applications must be cautious with the way they handle data and most importantly how they inform the user about this use.
Regulations
A new data regulation in the United Kingdom
A new bill titled the "Data Protection and Digital Information Bill" is currently being proposed in the United Kingdom. The initial consideration by the Public Bill Committee will be done on the 10th of May. Currently, the Parliament is calling for written evidence. The Bill would change many parts of the existing regime such as the definition of personal data, the processing of data for "legitimate interests", scientific research, the obligations of data controllers and processors or even the international transfers of personal data.
EU's Upcoming Pharmaceutical Legislation
Drug shortages in the cold months are common these last couple years, especially concerning those used in the case of respiratory infections.
The EU has to prepare for the coming months.
Availability accessibility, and affordability are at the center of this upcoming reform of the pharmaceutical legislation.
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